Orthopedic Knee Device Undergoes Safety Alert From FDA

Debra Sherman writing for Reuters reported that the US Food and Drug Administration released a Safety Alert, notifying healthcare providers that Johnson & Johnson’s DePuy unit has issued an urgent, Class I recall, for its LPS Diaphyseal Sleeve. The FDA said that thus far, it has received 10 reports of incidents in which fractures or looseness caused the orthopedic device, which is used for reconstructive knee surgery, to malfunction.

Fractures that occur at the taper joint of the sleeve could cause soft tissue to become compromised and result in infection, function loss, limb loss, or death, the agency cautioned in the Alert.

Another danger of knee replacement surgery.

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